2005N-0345 Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
FDA Comment Number : EC899
Submitter : Mr. David Paul Xavier Burch Date & Time: 10/17/2005 11:10:38
Organization : Mr. David Paul Xavier Burch
Category : Individual Consumer
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC drug product?
Yes; because this is needed by everyone concerned!(For example, abortion-inducing/producing birth control SHOULD NOT BE LEGAL: MUCH LESS OVER THE COUNTER!